Location Collegeville, PennsylvaniaUS
Job ID REQ-054813
Job Responsibilities:
Work as a principal engineer/scientist in a multi-disciplinary development team, liaising efficiently with Formulators, Modellers, automation experts, data scientists and device engineers, to deliver the work packages required to understand drug product unit operations and scale these-up effectively.
Actively participate in technical reviews on projects, lead the scale-up of processes, and ensure timely execution. Contribute to CMC and MPD team planning, agreeing priorities and coordinating PE&A activities that support delivery of objectives.
Ensure proper Process Engineering and PAT related decisions are taken at appropriate milestones within the project plan to accelerate early phase formulation and process design and minimize number of DOE's for scalability assessments and API consumption throughout the development life-cycle.
Make innovative contributions to the department by leading platform development workstreams to assess, develop and implement new manufacturing and/or PAT platforms. Be accountable for manufacturing and/or PAT platform robustness across the portfolio.
The job holder may act as an expert in specific unit operations and/or PAT technology. This expertise will be focused on platform and process primarily within the sterile portfolio.
Prepare and deliver Process Engineering and Analytics-relevant sections of technical presentations and respond to resulting questions. Identify and escalate Process Engineering and Analytics-related risks at scientific reviews.
Advance scientific understanding and improve current ways of working in field of expertise by actively championing deployment of new process engineering platforms, PAT tools and models for drug product development, participating in internal or external technical focus networks, external collaborations, and applying knowledge of the current literature.
Enable sound decisions by your influence in matrix teams, through depth of technical knowledge and effective communication, to collaborate actively with R&D Pilot Plants and Global Supply Chain manufacturing sites
Deliver the above in a precise and timely manner, adhering to safety and quality expectations. Comply with the requirements of Quality, Safety and GSK policies and procedures and ensure that GSK intellectual property is protected.
Nothing in this job description restricts management's right to assign or reassign duties and responsibilities of this job at any time
PhD in Chemical Engineering, Pharmaceutical Sciences, Biotechnology, Chemistry, Physics, mechanical engineering or any engineering field
Master's degree in Chemical Engineering, Pharmaceutical Sciences, Biotechnology, Chemistry, Physics, mechanical engineering or any engineering field
3-5 years of similar experience in protein formulation and drug delivery development experience
Bachelor's degree in Chemical Engineering, Pharmaceutical Sciences, Biotechnology, Chemistry, Physics, mechanical engineering or any engineering field
5-7 years of similar experience in protein formulation and drug delivery development experience
Preferred Experience: (candidates who meet BQs & these qualifications (PQs) especially qualify to be shortlisted for candidate submission)
The ideal candidate will have 2+ years of Steriles drug product - Process Engineering development and/or PAT experience; or MS degree with 5+ years of similar experience; or BS degree with 7+ years of experience.
Experience in Steriles drug product process development, PAT, characterization, scale -up and technology transfer modelling, and, to deliver processes that are well understood
Experience in the application of state-of-the-art laboratory equipment, equipment automation, data automation, PAT tools and modelling software.
Experience evaluating, developing, and qualifying manufacturing equipment.
Proven ability to lead collaboratively in a matrix style environment
Steriles product development including formulation, stability, process development/characterization and technical transfer
analytical and physical testing, and data analysis
Demonstration of data integrity principles
Working Environment
Must be able to work in a laboratory, controlled environments requiring personal protective equipment (e.g., lab coat, safety glasses, etc.) in laboratory
Job pace may be fast and job completion demands may be high
Must be able to remain in a stationary position more than 25% of the time
The person needs to occasionally move between labs, corridors, adjoining rooms, and buildings on-site
Frequently operate on instruments, objects, tools, or controls, which will require regularly bending,
Occasionally move or lift up to 25 pounds (potential for occasional lifting of up to 50 pounds)
Specific vision abilities required by this position include without limitation, the ability to observe details at close range distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus in order to perform the essential service functions of this position
Occasionally operates a computer and other office machinery, such as a calculator, copy machine, and computer printer
Employee may be required to handle hazardous waste according to local, state, and federal regulations
Duties may include identifying, handling, generating, accumulating, storing, and labeling hazardous waste
Potential risk to lab-based hazards including but not limited to extreme temperature, biological materials, and hazardous chemicals
May be required to complete Medical Clearance, Respiratory Protection Training, and Fit Testing to wear a respirator as protection against hazards present in the laboratory environment
The annualcompensation range for this full-time position is $$71,240.00 to $106,600.00. The final base pay offered to the successful candidate will be determined by factors including internal equity, work location, as well as individual qualifications, such as job-related skills, experience, and relevant education or training.